FDA.reportPublic FDA data

Alka-Seltzer Extra Strength Heartburn ReliefChews

Manufacturer
Bayer HealthCare LLC.
Effective date
2025-12-04
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:19:49

Label at a glance#

ProductAlka-Seltzer Extra Strength Heartburn ReliefChews
Active ingredientCALCIUM CARBONATE
Label structure11 sections

Indications and uses

for the relief of: acid indigestion heartburn sour stomach upset stomach associated with these symptoms

Dosage and administration

adults and children 12 years and over: fully chew then swallow 1 or 2 chewable tablets as symptoms occur, or as directed by as doctor children under 12 years: consult a doctor do not take more than 5 chewable tablets in a 24-hour period

Label contents#

Full prescribing information#

Active ingredient (in each chewable tablet)

OTC - ACTIVE INGREDIENT SECTION

Calcium carbonate 750 mg

Purpose

OTC - PURPOSE SECTION

Antacid

Uses

INDICATIONS & USAGE SECTION

for the relief of:

  • acid indigestion
  • heartburn
  • sour stomach
  • upset stomach associated with these symptoms

Warnings

WARNINGS SECTION

Do not use if

OTC - DO NOT USE SECTION

you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

presently taking a prescription drug. Antacids may interact with certain prescription drugs.

When using this product

OTC - WHEN USING SECTION

  • do not take more than 5 chewable tablets in a 24-hour period
  • do not use the maximum dosage of this product for more than 2 weeks except under the advice and supervision of a physician
  • constipation may occur

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 12 years and over: fully chew then swallow 1 or 2 chewable tablets as symptoms occur, or as directed by as doctor
  • children under 12 years: consult a doctor
  • do not take more than 5 chewable tablets in a 24-hour period

Other information

OTHER SAFETY INFORMATION

  • each chewable tablet contains: calcium 300 mg
  • contains FD&C Yellow No. 5 (tartrazine) as a color additive
  • store at room temperature. Avoid humidity.
  • close cap tightly after use

Inactive ingredients

INACTIVE INGREDIENT SECTION

acacia, carmine, carnauba wax, citric acid, corn starch, corn syrup, DL-alpha tocopherol, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, FD&C yellow #5 lake (tartrazine), FD&C yellow #6, FD&C yellow #6 aluminum lake, FD&C yellow #6 lake, flavors, hydrogenated coconut oil, hydrogenated vegetable oil, lecithin, medium chain triglycerides, methyl paraben, modified starch, phosphoric acid, pregelatinized modified starch, propyl paraben, propylene glycol, shellac, sodium benzoate, sorbic acid, sorbitol, sugar, titanium dioxide, water, white wax

Questions or comments?

OTC - QUESTIONS SECTION

Questions or comments?
1-800-986-0369 (Mon-Fri 9AM - 5PM EST)

Principle display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

assorted fruit

Alka-Seltzer

Calcium Carbonate / Antacid

Extra Strength

Heartburn ReliefChews

Fast

Powerful

relief

Bayer

60 CHEWABLE TABLETS

ASESHBRCASESHBRC

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308915calcium carbonate 750 MG (Ca 300 MG) Chewable TabletPSN7
308915calcium carbonate 750 MG Chewable TabletSCD7
308915calcium carbonate 750 MG (calcium 300 MG) Chewable TabletSY7

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CALCIUM CATION Pharmacologic Class Indexing3Indexing - Pharmacologic Class20230427

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130016500554592GTIN-13: 0016500554592
EAN-13: 0016500554592
GTIN-12: 016500554592
UPC-A: 016500554592
GTIN storage (14 digits): 00016500554592		AS ES HB RC.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0280-0042-08Alka-Seltzer Extra Strength Heartburn ReliefChews8 in 1 POUCHTABLET, CHEWABLE87
0280-0042-36Alka-Seltzer Extra Strength Heartburn ReliefChews36 in 1 BOTTLE, PLASTICTABLET, CHEWABLE367
0280-0042-60Alka-Seltzer Extra Strength Heartburn ReliefChews60 in 1 BOTTLE, PLASTICTABLET, CHEWABLE607
0280-0042-90Alka-Seltzer Extra Strength Heartburn ReliefChews90 in 1 BOTTLE, PLASTICTABLET, CHEWABLE907

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0280-00420280-0042-08, 0280-0042-36, 0280-0042-60, 0280-0042-90

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACACIA5C5403N26OIACT
SORBITOL506T60A25RIACT
RAW SUGAR8M707QY5GHIACT
WHITE WAX7G1J5DA97FIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
CARNAUBA WAXR12CBM0EIZIACT
.ALPHA.-TOCOPHEROL, DL-7QWA1RIO01IACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
HYDROGENATED COCONUT OILJY81OXM1OMIACT
CALCIUM CARBONATEH0G9379FGKACTIM
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)461P5CJN6TIACT
CORN SYRUP9G5L16BK6NIACT
SHELLAC46N107B71OIACT
SODIUM BENZOATEOJ245FE5EUIACT
SORBIC ACIDX045WJ989BIACT
WATER059QF0KO0RIACT
CARMINIC ACIDCID8Z8N95NIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PHOSPHORIC ACIDE4GA8884NNIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alka-Seltzer Extra Strength Heartburn ReliefChewsCALCIUM CARBONATEBayer HealthCare LLC.51759451-63a8-0fb4-e054-00144ff8d46c2025-12-04WarningsExact identifier
ndc (package): 0280-0042-08
ndc (package): 0280-0042-36
ndc (package): 0280-0042-90
ndc (package): 0280-0042-60
ndc (product): 0280-0042
ndc11 (package): 00280004290
ndc11 (package): 00280004236
ndc11 (package): 00280004208
ndc11 (package): 00280004260
spl id: 45261270-336f-5073-e063-6394a90acc38
spl set id: 51759451-63a8-0fb4-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.